May 2022 Report

May 2022 Report

New Drug and First Time Generic Report

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Monthly update of U.S. Food and Drug Administration (FDA) approvals impacting the workers' compensation industry. myMatrixx's report includes new drug and indication approvals, discontinuation and withdrawals, new dosages or formulations of existing products and newly available generics in the last 12 months.

Monthly Drug News

A generic version of Horizon Pharma’s Pennsaid® 2% (diclofenac sodium topical solution) is now available. Other topical products containing diclofenac are already available as generics, but Apotex Inc. is the first with the 2% solution.

Impact to Workers’ Comp

Topical diclofenac is a popular product in workers’ compensation, whether it is the 1% gel, 1.3% patch or solution (either 1.5% or 2%). In retail settings, Pennsaid 2% tends to be the most costly formulation, so its generic availability is a welcome addition.

For any questions about the use of Pennsaid, diclofenac, or other topical NSAIDs and potential relatedness to a claim, please consult with your myMatrixx pharmacist.

New Brand Drug Pipeline

Medication (Brand name) Drug Class Therapeutic Use Status Update
Nalmefene Injection Opioid Agonist Opioid Overdose Anticipated summer 2022. Approved February 8, 2022.

Baclofen Granules (Lyvispah™)

Muscle Relaxant Muscle Spasms Launch pending. Approved November 22, 2021.
Buprenorphine Depot Injection (Brixadi™) Opioid Agonist Treatment of
Opioid Addiction
FDA review pending.
Oxycodone (Aximris XR™) Opioid Analgesic –
Extended Release
Pain FDA review pending.

Meloxicam/Rizatriptan

NSAID/Serotonin Agonist

Migraine Headache FDA review pending.

Generic Pipeline

Medication (Brand name) Drug Class Therapeutic Use Status Update
Vilazodone (Viibryd®) Antidepressant Depression Patent set to expire June 2022.
Dabigatran (Pradaxa®) Anticoagulant Treatment/Prophylaxis of Deep Vein Thrombosis First patent set to expire December 2021. Generic anticipated June 2022.
Oxycodone HCl (Oxaydo®) Opioid Agonist Pain Generic exclusivity anticipated in 2022.
Apixaban (Eliquis®) Anticoagulant Treatment/Prophylaxis of Deep Vein Thrombosis Generics approved December 23, 2019, but settlements expected to delay launch for at least a few years.

Available in the Last 12 Months

Medication (Brand name) Drug Class Therapeutic Use Status Update
Naloxone Injection (Zimhi™) Opioid Antagonist Opioid Overdose March 2022
Celecoxib/Tramadol (Seglentis®) NSAID/Opioid Agonist Pain March 2022
Baclofen Oral Suspension (Fleqsuvy™) Muscle Relaxant Muscle Spasms March 2022
Celecoxib Oral Liquid (Elyxyb™) NSAID Migraine Headache Treatment February 2022
Naloxone Nasal Spray (Kloxxado™) Opioid Antagonist Opioid Overdose August 2021

Newly Available Generics

Medication (Brand name) Drug Class Therapeutic Use Status Update
Diclofenac Sodium 2% (Pennsaid®) Solution Topical NSAID Pain May 2022

Diclofenac Potassium (Zipsor®) Capsule

NSAID Pain March 2022
Naloxone HCl (Narcan®) Nasal Spray Opioid Antagonist Opioid Overdose December 2021
Zolmitriptan Nasal Spray (Zomig®) Serotonin Agonist Migraine Headache Treatment November 2021
Nebivolol (Bystolic®) Beta Blocker Beta Blocker September 2021
Ibuprofen/Famotidine (Duexis®) NSAID/H-2 Receptor Antagonist Pain/Inflammation August 2021

Discontinuations & Withdrawals

Medication (Brand name) Drug Class Therapeutic Use Status Update
Hydrocodone ER Capsules (Zohydro® ER) Opioid Agonist Pain Manufacturer has stopped distribution and FDA has rescinded approval effective February 2022.

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